Scroll for Important Safety Information and Indication

Hepatic impairment: TORISEL is contraindicated in patients with bilirubin >1.5 x ULN and should be used with caution when treating patients with mild hepatic impairment (bilirubin >1-1.5 x ULN or AST >ULN but bilirubin ≤ULN). If TORISEL must be given to patients with mild hepatic impairment, reduce the dose of TORISEL to 15 mg/week. In a phase 1 study, the overall frequency of ≥grade 3 adverse reactions and deaths, including deaths due to progressive disease, was greater in patients with baseline bilirubin >1.5 x ULN

Hypersensitivity/Infusion reactions: Hypersensitivity/infusion reactions, including flushing, chest pain, dyspnea, hypotension, apnea, loss of consciousness, hypersensitivity, and anaphylaxis, may occur very early in the first infusion or with subsequent infusions. Pretreat with an H1 antihistamine. TORISEL infusion should be interrupted in patients with infusion reactions and appropriate therapy given

Hyperglycemia/Hyperlipidemia: Serum glucose, serum cholesterol, and triglycerides should be tested before and during TORISEL treatment. TORISEL is likely to result in hyperglycemia and hyperlipidemia. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy and/or lipid-lowering agents, respectively

Infections: TORISEL may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections. Pneumocystis jiroveci pneumonia (PJP), including fatalities, has been reported with TORISEL. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents. Prophylaxis of PJP should be considered in patients taking concomitant corticosteroids or other immunosuppressive agents

Interstitial lung disease (ILD): Cases of ILD, some resulting in death, have occurred. Some patients were asymptomatic or had minimal symptoms. Patients should undergo baseline radiography prior to TORISEL therapy and periodically thereafter, even in the absence of clinical respiratory symptoms. Follow patients closely and, if clinically significant respiratory symptoms develop, consider withholding TORISEL until recovery of symptoms and radiographic improvement of pneumonitis findings. Some patients required TORISEL discontinuation and/or treatment with corticosteroids and/or antibiotics. Opportunistic infections such as PJP should be considered in the differential diagnosis

Vaccinations: Live vaccinations and close contact with those who received live vaccines should be avoided

Embryo-fetal toxicity: TORISEL can cause fetal harm to pregnant women. Patients and their partners should be advised of the potential risk to a fetus, and to use effective contraception during TORISEL treatment and for 3 months after the last dose

Infertility: Based on the findings in animal fertility studies, male and female fertility may be compromised by the treatment with TORISEL. It is not known if the effects on fertility in animal studies were reversible

Lactation: Advise lactating women not to breastfeed during TORISEL treatment and for 3 weeks after the final dose

Elderly patients: Elderly patients may be more likely to experience certain adverse reactions including diarrhea, edema, and pneumonia

CYP3A coadministration: Strong inducers of CYP3A4/5 (eg, dexamethasone, rifampin) and strong inhibitors of CYP3A4 (eg, ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended

Avoid St. John’s Wort which may decrease TORISEL plasma concentrations, and grapefruit juice which may increase plasma concentrations of the major metabolite of TORISEL

Concomitant use of TORISEL with sunitinib: The combination of TORISEL and sunitinib resulted in dose-limiting toxicity (grade 3/4 erythematous maculopapular rash, and gout/cellulitis requiring hospitalization)

Prognostic Risk

Approximately 1 out of 4 patients has poor prognostic risk

20% to 26% of patients with advanced RCC are poor risk at the time of the 1st-line treatment decision*

*Percentage of poor-risk patients based on published analyses using the Database Consortium, International Kidney Cancer Working Group, Cleveland Clinic Foundation, and Memorial Sloan-Kettering Cancer Center risk models.1-5

Prognostic risk is a predictor of patient survival

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer list prognostic risk stratification as an important consideration for patients with advanced RCC6

Evidence shows that prognostic risk is one of a number of factors to consider when managing advanced RCC1,7

Support & Services

Scroll for Important Safety Information and Indication

Hepatic impairment: TORISEL is contraindicated in patients with bilirubin >1.5 x ULN and should be used with caution when treating patients with mild hepatic impairment (bilirubin >1-1.5 x ULN or AST >ULN but bilirubin ≤ULN). If TORISEL must be given to patients with mild hepatic impairment, reduce the dose of TORISEL to 15 mg/week. In a phase 1 study, the overall frequency of ≥grade 3 adverse reactions and deaths, including deaths due to progressive disease, was greater in patients with baseline bilirubin >1.5 x ULN

Hypersensitivity/Infusion reactions: Hypersensitivity/infusion reactions, including flushing, chest pain, dyspnea, hypotension, apnea, loss of consciousness, hypersensitivity, and anaphylaxis, may occur very early in the first infusion or with subsequent infusions. Pretreat with an H1 antihistamine. TORISEL infusion should be interrupted in patients with infusion reactions and appropriate therapy given

Hyperglycemia/Hyperlipidemia: Serum glucose, serum cholesterol, and triglycerides should be tested before and during TORISEL treatment. TORISEL is likely to result in hyperglycemia and hyperlipidemia. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy and/or lipid-lowering agents, respectively

Infections: TORISEL may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections. Pneumocystis jiroveci pneumonia (PJP), including fatalities, has been reported with TORISEL. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents. Prophylaxis of PJP should be considered in patients taking concomitant corticosteroids or other immunosuppressive agents

Interstitial lung disease (ILD): Cases of ILD, some resulting in death, have occurred. Some patients were asymptomatic or had minimal symptoms. Patients should undergo baseline radiography prior to TORISEL therapy and periodically thereafter, even in the absence of clinical respiratory symptoms. Follow patients closely and, if clinically significant respiratory symptoms develop, consider withholding TORISEL until recovery of symptoms and radiographic improvement of pneumonitis findings. Some patients required TORISEL discontinuation and/or treatment with corticosteroids and/or antibiotics. Opportunistic infections such as PJP should be considered in the differential diagnosis

Vaccinations: Live vaccinations and close contact with those who received live vaccines should be avoided

Embryo-fetal toxicity: TORISEL can cause fetal harm to pregnant women. Patients and their partners should be advised of the potential risk to a fetus, and to use effective contraception during TORISEL treatment and for 3 months after the last dose

Infertility: Based on the findings in animal fertility studies, male and female fertility may be compromised by the treatment with TORISEL. It is not known if the effects on fertility in animal studies were reversible

Lactation: Advise lactating women not to breastfeed during TORISEL treatment and for 3 weeks after the final dose

Elderly patients: Elderly patients may be more likely to experience certain adverse reactions including diarrhea, edema, and pneumonia

CYP3A coadministration: Strong inducers of CYP3A4/5 (eg, dexamethasone, rifampin) and strong inhibitors of CYP3A4 (eg, ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended

Avoid St. John’s Wort which may decrease TORISEL plasma concentrations, and grapefruit juice which may increase plasma concentrations of the major metabolite of TORISEL

Concomitant use of TORISEL with sunitinib: The combination of TORISEL and sunitinib resulted in dose-limiting toxicity (grade 3/4 erythematous maculopapular rash, and gout/cellulitis requiring hospitalization)